Healthy Heart Amputation Rehabilitation Treatment (H.A.R.T)

NCT00038285 | Completed Phase 2

• 1 other identifier: A2830R
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

In the VA, we are achieving progress in decreasing amputation rates through early identification and multidisciplinary treatment of patients at risk for limb loss. Despite these accomplishments, however, clinical outcomes post-amputation, especially for PVD patients, have changed little because of patients' poor cardiovascular condition complicated by the injurious consequences of imposed inactivity begun in the preoperative period and continuing through convalescence. If not aggressively managed throughout all phases of recovery, these problems quickly render patients, already at risk, incapable of the rigors of rehabilitation as well as lead to reamputation, rehabilitation failure, and secondary complications. In our research, we are trying to transform this clinical scenario by applying what has succeeded in cardiac rehabilitation to services provided to amputees. In a series of studies, we are studying how to incorporate secondary CV risk factor modification and aggressive exercise interventions into conventional amputation rehabilitation through a program that we have named Healthy Heart Amputation Rehabilitation Therapy (Healthy H.A.R.T.). Our goal is to better: 1) increase aerobic capacity and promote rehabilitation achievements and quality of life, and 2) prevent postoperative complications and curtail further peripheral vascular deterioration through interventions found successful in cardiac rehabilitation. The basic assumption of this study will be that cardiovascular status and, thus, aerobic capacity is a most critical factor for rehabilitation success.

Conditions

Vascular Disease

Keywords

Amputation; Cardiovascular Disease; PVD

Interventions

Amputation Prevention PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Peripheral Vascular Disease

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center

Houston, Texas, United States

Location

MeSH Terms

Conditions

Vascular Diseases; Cardiovascular Diseases

Study Officials

• David Wolff, Ph.D. Special Assistant to the Director

  Program Analysis and Review Section (PARS), VA Rehabilitation Research & Development Service

• Wijegupta Ellepola, Program Analyst

  Program Analysis and Review Section (PARS), VA Rehabilitation Research and Development Service

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: May 29, 2002
• First Posted: May 30, 2002
• Study Start: April 1, 2002
• Study Completion: March 1, 2005
• Last Updated: January 21, 2009

Record last verified: 2002-05

Locations

US (1)